MIRACLE-EAR MODEL HL

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ENZYGNOST PLATELET FACTOR 4 (PF4) KIT

FDA 510(k)

FDA Class 2 ·Hematology

AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

ISOTRAK AMYLASE ISOENZYME CONTROL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

EMIT II PLUS COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANA SENSITIVITY/SPECIFICITY CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

CONTROL PLASMA N, PROC CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N LATEX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPI/TEX ASO STANDARD SERUM

FDA 510(k)

FDA Class 1 ·Microbiology

N PROTEIN STANDARS SY

FDA 510(k)

FDA Class 2 ·Immunology

MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

OPUS ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology